UC Davis Health Clinical Studies

A Study of the Experimental Prevena™ device (Incisional Negative Pressure Wound Therapy) for Soft Tissue Sarcoma Wounds

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Patients with sarcomas (tumor in bone or soft tissue) who receive radiation before surgery have a greater chance of complications in wound healing. This research study will test a wound dressing called Negative Pressure Wound Therapy (NPWT). NPWT is a wound sponge attached to a gentle suction device. It is more effective at preventing infection of the surgical wound than standard dry gauze wound dressing. The Prevena™ device (NPWT) is FDA approved for use on incisions. This will be considered the investigational dressing. The NPWT device is a foam sponge that is placed over the incision after surgery, and provides a low pressure gentle suction on the wound. It is sealed with an adhesive dressing. The traditional standard dry gauze dressing will be considered the control dressing for this study

Device study
Any, age 18 years or older

A Study of the Experimental EXPLORER PET/CT Medical Scanner in Healthy Volunteers

Help us test the performance of the world's first full-body EXPLORER scanner

We're inviting healthy volunteers to take part in an imaging research study. The purpose of this study is to test the performance of a new experimental medical scanner. The scanner, called EXPLORER, is the first total-body PET/CT medical scanner that is able to scan the entire human body and its organs at once. It is 40 times more efficient and has the potential to make a big impact in medical care and research. The EXPLORER scanner is the brainchild of UC Davis Health scientists envisioned 13 years ago as a scanner that could capture images quicker, better, or with less radiation than current scanners PET/CT scanning is a very safe medical imaging technique that tracks and maps out the movement of tiny amounts of radioactively-tagged sugars after injection in a body. Across the world millions of PET scans happen in patients each year.

Device Study
Any, age 18-100

A Study of Experimental PET Scan for Renal Cell Carcinoma (kidney cancer)

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The current treatment for kidney cancer only benefits some patients. It can be costly and toxic. To check if treatment is working, doctors use computed tomography (CT) and/or magnetic resonance imaging (MRI). This imaging is done approximately two months after cancer treatment. In some cases where treatment is not working, those patients are unnecessarily exposed to toxic treatment. They can then switch to other potentially effective therapy. The purpose of this study is to learn a new way of imaging cancer early during the treatment course (two weeks). This will help determine if the treatment is effective. We will explore the benefit of functional PET technique for earlier prediction of cancer response.

Diagnostic Test study
Any, age 21 to 80 years old

A Study of the Experimental CorMatrix Cor TRICUSPID ECM Device for Tricuspid Valve Replacement

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This study will determine if the experimental Cor TRICUSPID ECM Valve is a safe replacement of your natural Tricuspid Valve. This is an Early Feasibility Study. That means that it is a small study of a new kind of device. It has only been implanted in a limited number of human subjects. There may be less nonclinical information and testing than would be required to start a larger study. The study is designed to gain initial insights into the basic safety and functionality of the study device. Participation in this study will involve placement of the experimental device Cor TRICUSPID ECM Valve. It will replace your dysfunctional tricuspid heart valve. Over time, the design of the CorMatrix Cor TRICUSPID ECM Valve may allow your own cells to grow into and reconstruct the tricuspid valve structure. This will result in long-term tissue repair with your own natural tissue.

Device study
Any, age 1 to 70 years old

ILUMIEN IV: A Study of OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation (OPTIMAL PCI)

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Coronary Stent placement is guided by imaging techniques. The most commonly used technique is Coronary Angiography, which uses x-rays. The doctors in your hospital also use OCT (optical coherence tomography). OCT is an imaging technique. It allows for visualization of the stent and artery wall using light, like having a microspic flashlight placed in your heart artery. The primary purpose of this study is to compare OCT to angiography during coronary stent placement. The physicians participating in this study are experienced users of angiography and OCT in routine clinical practice. There are two phases of the study. The first phase in a roll-in phase. During this time, up to 3 persons at UC Davis will be enrolled who will have the stenting procedure done using OCT. This roll in phase is to show that the physicians can follow the OCT stent guidance procedures. The second phase of the study will enroll persons to be randomized to have the stent placed with angiography or OCT. The study physician will let you know at time of consent if you will be part of the roll-in phase or the randomized phase.

Device study
Any, age 18 years or older

A Study of the Experimental Neuro-Spinal Scaffold™ Device for Complete Thoracic AIS A Spinal Cord Injury

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The purpose of this study is to test the safety and benefit of a new medical device. This device is implanted into the injured spinal cord for a recent spinal cord injury. The procedure to implant the medical device may be added to the usual, standard treatment for spinal cord injury. The study doctor will attempt to perform your surgery as soon as possible. The medical device is experimental and is not approved by the FDA. There is no evidence that the medical device will be of any benefit to you. However, the study will look at whether the new medical device helps improve the medical condition of patients with recent spinal cord injuries.

Device study
Any, age 16 to 70 years old

A Study of the FamilyLink Videoconferencing System and Breastfeeding

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This research study will determine whether viewing your baby while pumping changes the amount and/or content of your breastmilk. We also want to learn if viewing your baby changes your experience with pumping. You are invited to be in this study because you are a mother of a patient in our Neonatal Intensive Care Unit (NICU) who is currently pumping breastmilk. FamilyLink is a videoconferencing software used to view your baby remotely. Participation in this study will involve three sessions pumping breastmilk while using FamilyLink. Three sessions will be done without using FamilyLink. After each session you will complete a short survey and bring your pumped milk into the NICU. Which sessions you use FamilyLink for will be randomly assigned.

Behavioral study
Female, age -1 years or older

A Comparison Study of the Experimental Human Acellular Vessel For Dialysis in End-Stage Renal Disease

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This research study is for patients with kidney failure, undergoing hemodialysis with a dialysis catheter. For long term hemodialysis, it's best to create a more permanent and safe route to connect your blood stream to the dialysis machine. There are many ways to do this including surgically implanting a graft (a short piece of tubing). Another option is to surgically connect your artery and vein. This connection is called an autologous arteriovenous fistula or AVF. This study will compare a new investigational graft developed by Humacyte (the Human Acellular Vessel or HAV) with an AVF. This study will compare the ability of the HAV to function as an alternative to AVF for vascular access during hemodialysis.

Biological study, Phase 3
Any, age 18 years or older

A Study of the Effectiveness and Safety of Oxiplex® Gel to Reduce Pain and Symptoms Following Lumbar Disc Surgery

Please consider joining this clinical research study if you are having surgery for a herniated lumbar disc.

This study will examine the safety and effectiveness of an experimental device called Oxiplex. Oxiplex gel is not yet approved in the U.S. by the FDA. Oxiplex may help prevent some of the side effects that can occur after lower back spine surgery. This includes leg pain not resolved with surgery, back pain, and neurological symptoms such as weakness and numbness. Oxiplex gel is a sterile, bioresorbable (dissolves and absorbs into the body) product. The gel does not require removal after surgery and clears from the body. Oxiplex may improve post-surgical leg and back pain by providing a physical barrier for the nerves around your surgical site. It is applied during the lumbar spine surgery to coat the sensory nerves. This barrier isolates the nerves from tissues and fluid that may cause inflammation in that area.

Device study
Any, age 22 to 70 years old

Help us design better tools to manage continuous IV immunotherapy in acute lymphoblastic leukemia. Participate in a research study

We aim to understand the experiences of patients, caregivers, and nurses with continuous IV immunotherapy

The goal of this study is to learn about the experiences of patients, caregivers, and nurses with continuous IV immunotherapy. We want to understand the needs and challenges in managing continuous IV immunotherapy and how information about this therapy was provided to the patients, caregivers, and nurses. We aim to improve how we educate and support patients, family members, and nurses with this therapy in the future. We hope that the insights from this study will help us develop digital health or other tools.

Observation, workshop
Any, age 18 year or over
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